Over the past few months, sev­er­al bio­phar­ma com­pa­nies like GSK, Mer­ck, Al­ny­lam and Bio­Marin have said they are mon­i­tor­ing how the lo­ca­tion of their drugs’ in­tel­lec­tu­al prop­er­ty could be rel­e­vant to Pres­i­dent Don­ald Trump’s forth­com­ing in­dus­try-spe­cif­ic levies.

An IP for a drug is in the coun­try where its patent is filed. For the drug to be made and sold else­where, the IP is li­censed out to the com­pa­ny’s sub­sidiaries in those coun­tries.

The twist is that IPs are of­ten not in the US for tax pur­pos­es. Many com­pa­nies hold IP in coun­tries with low­er in­come tax­es than the US, like Ire­land and Switzer­land, said Mol­lie Sitkows­ki, a trade com­pli­ance part­ner at US law firm Fae­gre Drinker.  

Now, the threat of phar­ma levies has com­pa­nies re­con­sid­er­ing the lo­ca­tion of their IPs.

BioN­Tech said it's stop­ping work on an ex­per­i­men­tal cell ther­a­py in cer­tain in­di­ca­tions, and is wind­ing down cell ther­a­py man­u­fac­tur­ing at its Gaithers­burg, MD site.

“We have made the dif­fi­cult de­ci­sion to dis­con­tin­ue cell ther­a­py man­u­fac­tur­ing at our site in Gaithers­burg by the end of this year, re­sult­ing in a re­duc­tion in head­count in the cell ther­a­py tech­ni­cal op­er­a­tions team,” a BioN­Tech spokesper­son told End­points News in an email. “Over the com­ing months, we will be re­align­ing Gaithers­burg ca­pa­bil­i­ties to sup­port the com­pa­ny’s pipeline.”

The Ger­man com­pa­ny is lay­ing off 63 staffers at the site, ac­cord­ing to a WARN no­tice.

BioN­Tech ac­quired the fa­cil­i­ty from Gilead’s cell ther­a­py unit Kite in 2021. The site was mak­ing BioN­Tech’s ex­per­i­men­tal CAR-T treat­ment called BNT211, which is the com­pa­ny’s on­ly clin­i­cal-stage CAR-T ther­a­py.

No­vo Nordisk has end­ed its un­like­ly part­ner­ship with Hims & Hers af­ter less than two months.

In late April, the phar­ma gi­ant start­ed al­low­ing Hims, along with oth­er tele­health com­pa­nies, di­rect ac­cess to its brand-name weight loss drug We­govy at a dis­count­ed price.

The col­lab­o­ra­tion was sur­pris­ing be­cause Hims has been one of the most promi­nent pre­scribers of com­pound­ed semaglu­tide, the main in­gre­di­ent in We­govy, mak­ing it a key com­peti­tor to No­vo. At the time, Hims said the part­ner­ship was the start of a long-term col­lab­o­ra­tion.

The re­la­tion­ship ap­par­ent­ly soured quick­ly. No­vo said Mon­day that it is no longer work­ing with Hims be­cause of the tele­health com­pa­ny’s al­leged sale “of il­le­git­i­mate, knock­off ver­sions of We­govy.”

Am­gen in­tends to dose its long-act­ing obe­si­ty shot Mar­i­Tide at a low­er lev­el in its Phase 3 than it did in Phase 2, af­ter the drug’s side ef­fects proved un­man­age­able in mid-stage re­search.

The ad­verse events in the mid-stage study, de­tailed in a New Eng­land Jour­nal of Med­i­cine pa­per, alarmed the com­pa­ny’s in­vestors, send­ing Am­gen’s stock AMGN down 5.8% at mar­ket close Mon­day.

The com­pa­ny said it will use a slow­er titra­tion sched­ule in its piv­otal study, with the start­ing dose just 21 mg and the high­est fi­nal tar­get dose at 350 mg once a month. The Phase 2 study dosed the drug — a GLP-1 ag­o­nist but a GIP an­tag­o­nist — ei­ther with­out titra­tion at all, or start­ing at 70 mg and go­ing as high as 420 mg once month­ly.

Mul­ti­ple agency sources said FDA Com­mis­sion­er Mar­ty Makary was be­hind a short-lived re­quest last week to re­ject a rare dis­ease drug ap­pli­ca­tion from KalVista Phar­ma­ceu­ti­cals that re­mains un­der agency re­view.

The re­jec­tion re­quest was un­suc­cess­ful, as se­nior FDA sci­en­tists pushed back in­ter­nal­ly and raised le­gal con­cerns that such an ac­tion would be “ar­bi­trary and capri­cious,” ac­cord­ing to in­ter­nal mes­sages re­viewed by End­points News. Even still, the pur­port­ed at­tempt by the po­lit­i­cal­ly ap­point­ed head of the agency to in­ter­vene in the FDA’s typ­i­cal re­view process was de­scribed by three FDA sources with knowl­edge of the mat­ter as ex­tra­or­di­nary in­ter­fer­ence in­to the agency’s day-to-day op­er­a­tions. The sources spoke with End­points on the con­di­tion of anonymi­ty. An HHS spokesper­son de­nied such a re­quest was made by FDA lead­er­ship.